First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
- Registration Number
- NCT05413668
- Lead Sponsor
- Reveal Pharmaceuticals Inc.
- Brief Summary
The objectives of this trial are:
1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers
2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.
- Detailed Description
The first in human study is intended to evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers, and to determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Male or female subjects
- Healthy subjects aged 18 to 55 years inclusive
- Suitable veins for phlebotomy, cannulation, or repeated venipuncture
- Have a body mass index between 18 and 32 kg/m^2 (inclusive); weigh at least 55 kg.
- Appropriately completed written informed consent prior to any study specific procedures.
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening
- Vital sign abnormalities at screening or admission
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease; neurological or psychiatric disorder, as judged by the investigator
- Positive pregnancy test at screening or admission
- History of alcohol abuse
- History of drug abuse
- Use of nicotine-containing products within 12 months of study start
- Use of medication except topical products without significant systemic absorption
- Known allergies to any component of RVP-001
- Subjects who have received any investigational product (IP) in a clinical research study within 5 IP half-lives or 30 days prior to first dose.
- Donation of plasma within 7 days prior to dosing; significant donation or loss of blood within 30 days prior to the first dosing.
- Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RVP-001 group RVP-001 4 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg. Placebo group Placebo 4 Cohorts of 2 subjects each will receive placebo (saline).
- Primary Outcome Measures
Name Time Method Pharmacokinetic (PK) Parameter Cmax pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose Cmax = maximum observed blood plasma concentration of RVP-001
PK Parameter Tmax pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose tmax = time of maximum observed plasma concentration of RVP-001
PK Parameter t1/2 pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose t1/2 = terminal elimination half-life of RVP-001
PK Parameter Cl pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose Cl = total body clearance calculated after a single IV administration of RVP-001
PK Parameter Vd pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose Vd = volume of distribution calculated after a single IV administration of RVP-001
- Secondary Outcome Measures
Name Time Method % RVP-001 Dose Excreted pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose mean % of RVP-001 excreted from urine from 0 -120 hours post dose
Related Research Topics
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Trial Locations
- Locations (1)
Quotient Sciences
🇺🇸Miami, Florida, United States